As the pharmaceutical and biotech industries continue to innovate at a rapid pace, the demand for fill/finish capabilities has never been greater. From the pandemic-driven surge in vaccine production to the current boom in GLP-1 therapeutics, CDMOs are playing an increasingly critical role in supporting the delivery of complex medicines.
With rising demand comes new challenges: capacity constraints, shifting regulatory expectations, and the unique requirements of emerging modalities, like cell and gene therapies, are reshaping the fill/finish landscape.
We sat down with Nithin Stephen, Director of Commercial Development specializing in Drug Product at Resilience, to discuss the key trends influencing the fill/finish industry, how CDMOs are navigating, and what lies ahead for CDMOs and their partners. Whether you're navigating capacity planning, considering a CDMO partnership, or tracking innovation in manufacturing, this conversation offers valuable insights into where the market is headed.
The demand for fill/finish services has surged significantly in recent years, driven by global health trends. Just as the COVID-19 pandemic led to a sharp increase in fill/finish demand for vaccines and affiliated therapeutics, the explosive demand for GLP-1 products in the last few years has further accelerated the need for these services.
The indirect effect of the demand spike for GLP-1s is the displacement of capacity for non-GLP-1 sterile injectable drug product manufacturing. Customers are looking for new CDMOs to diversify their portfolio to readily access fill/finish capacity. However, there are not many CDMOs available with open capacity - most of them are going through expansions that will provide capacity in the next 1 to 2 years.
Some CDMOs are trying to address capacity requirements via acquisition of other plants. Resilience was able to do this with the acquisition of AstraZeneca’s fill/finish and device assembly plant outside of Cincinnati, Ohio back in 2022.
Drug product manufacturing and fill/finish technology for biologics and gene therapy is well established. CDMOs are maintaining their existing fill/finish capabilities while expanding with new isolator-based, EU GMP Annex 1 compliant fill lines. Cryo-handling is critical for gene therapy fill/finish, therefore the quantity of vials filled during a batch is small in comparison to traditional modalities and has timing constraints due to the product sensitivity to external conditions. CDMOs also are expanding their packaging capabilities to provide full end-to-end services.
Cell therapy is still a developing field for fill/finish. Allogenic cell therapy is where traditional fill/finish technology can be used, but more innovation is needed here to expand the fill/finish scope within cell therapies in general.
mRNA vaccine fill/finish is very similar to biologics, however depending on the formulation, the CDMO may require capabilities to formulate and supply lipid nano particles (LNP) to house the mRNA. Again, cryo-handling is critical for mRNA products. A unique need that CDMOs are looking to meet is the seasonal availability requirement for mRNA vaccines. This is a challenging aspect of managing a CDMO business where you had products with steady monthly demand vs. mRNA vaccines with an increased demand for products over a handful of months depending on when they are required to be released to market.
Good audit history, commercial supply expertise, EU GMP Annex 1 compliant aseptic processing and fill/finish operations are critical to being considered a top tier CDMO now. Clients looking for fill/finish capacity value a CDMO with good regulatory standing as well excellent quality culture at the site level. In terms of equipment, it is critical to have isolator-based technology to ensure sterility during fill/finish process. Good quality systems, metrics and analytical capabilities are the pillars of a full-service fill/finish CDMO.
Within the GLP-1 market – increased competition for market space will be seen with alternatives to today’s leading diabetes and weight loss products. The generic market of GLP-1 will grow to meet the need for low-cost option for diabetes and weight loss treatments.
Outside of the GLP-1 market, due to capacity displacement by GLP-1 products, CDMOs should be ready with capacity to meet non-GLP-1 fill/finish needs.
Increased demand for device assembly and packaging capabilities can be expected since the trend of in-home drug administration is expected to continue to grow into future years. This includes products related to diabetes, weight loss, vaccinations and other maintenance drugs. Growth in ambient and cold storage is expected to grow linear to the amount of fill/finish capacity growth.
Since the acquisition of an AstraZeneca manufacturing site in Cincinnati in 2022, Resilience has continued to expand drug product manufacturing capacity to meet market demands, adding new lines for vials, pre-filled syringe (PFS), cartridges, device assembly and packaging, as well as investments in general facility upgrades for increased efficiencies. We recently announced a partnership with Jobs Ohio and REDI Cincinnati to expand into a 190,000 sq. ft. facility to add highly automated Device Assembly and Packaging capabilities for aseptic drug product filled at the Cincinnati location. Additionally, this location will add significant cold and ambient storage capacity to support the increasing demand. Resilience continues to partner with customers developing new technologies and has capacity available now and in the future for vials, PFS and cartridges.
Interested in seeing if our services may be the right fit for your Drug Product needs? Take our short Assessment to get a head start in determining if our fill/finish capacity and expertise are the right fit for you, or connect with our experts and get a conversation started.